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Serving 500+ biopharmaceutical companies globally:

Covington
Harvard Business School
Cantor Fitzgerald
US Department of Justice
Fish and Richardson
AstraZeneca
UBS
Teva
US Army
Express Scripts

Generated: September 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021802

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NDA 021802 describes FOCALIN XR, which is a drug marketed by Novartis and is included in one NDA. It is available from six suppliers. There are two patents protecting this drug and six Paragraph IV challenges. Additional details are available on the FOCALIN XR profile page.

The generic ingredient in FOCALIN XR is dexmethylphenidate hydrochloride. There are five drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.

Summary for NDA: 021802

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:2
Therapeutic Class:Central Nervous System Agents

Pharmacology for NDA: 021802

Suppliers and Packaging for NDA: 021802

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 021802 NDA Novartis Pharmaceuticals Corporation 0078-0430 0078-0430-05 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0430-05)
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 021802 NDA Novartis Pharmaceuticals Corporation 0078-0431 0078-0431-05 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0431-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength5MG
Approval Date:May 26, 2005TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Nov 1, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION
Patent:► SubscribePatent Expiration:Nov 1, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:May 26, 2005TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Nov 1, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION

Expired Orange Book Patents for NDA: 021802

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-008Apr 21, 2011► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-008Apr 21, 2011► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-002May 26, 2005► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-003May 26, 2005► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-006Aug 11, 2010► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-007Apr 21, 2011► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-003May 26, 2005► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-004Aug 1, 2006► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-002May 26, 2005► Subscribe► Subscribe
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-005Oct 23, 2009► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
McKinsey
Express Scripts
Johnson and Johnson
Harvard Business School
Fish and Richardson
Covington
Medtronic
Daiichi Sankyo
Cerilliant

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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